Phlebotomy licensure is the process by which various regulatory bodies regulate the practice of phlebotomy within its jurisdiction through licensure. In many countries a license is not required, or is obtained through other broader qualifications (such as a medical license), while in others, professional phlebotomists are separately licensed.
In most countries, there is not a dedicated a profession to phlebotomy, but it falls under the responsibility of other allied health professions such as nursing.[1][2][3]
Asia
China
In China, there are no national phlebotomy regulations, and phlebotomy is primarily performed by nurses, though Chinese nursing education offers limited training in phlebotomy quality control. [4]
Europe
United Kingdom
Phlebotomists need not by licensed in the UK, but training can be provided on-the-job, sometimes with the support of the National Association of Phlebotomists.[5] The skills required may also be monitored through broader monitoring requirements, such as the licence to practice of the General Medical Council.
In the United States there are no federal phlebotomy training or certification requirements, though several states have imposed their own requirements. In 2024, four states require licensure for phlebotomy: California, Louisiana, Nevada, and Washington.
In 2001, California enacted phlebotomy licensure after an on-the-job trained phlebotomist was found to be re-using needles. Following California, several states including Massachusetts and Missouri attempted to introduce either licensure or training/educational requirements, but the bills died.[6][7][8]
Phlebotomy licensure advocates claim that the licensure would enhance the quality of personnel, while the laboratory industry opposes phlebotomy licensure as an unnecessary cost.[9][10][11]
Phlebotomy is not without risk, and more challenging patients increase the chance of complications.[12] However, without licensure, it can be difficult to hold bad actors accountable.
Increasingly, a number of healthcare facilities are rolling phlebotomy duties into their patient care technician roles or other allied health roles.[13][14]
A number of FDA 510k cleared devices, such as the BD Minidraw have been introduced to enable the drawing of blood without a phlebotomist.[15] Additionally, there are devices to help aid non-phlebotomists more readily find veins.[16]
Certifications
There are several national phlebotomy certifications in the US.[17][18][19]
List of Phlebotomy Certifications in the United States
^Simundic, Ana-Maria; Cornes, Michael; Grankvist, Kjell; Lippi, Giuseppe; Nybo, Mads; Kovalevskaya, Svjetlana; Sprongl, Ludek; Sumarac, Zorica; Church, Stephen (1 August 2013). "Survey of national guidelines, education and training on phlebotomy in 28 European countries: an original report by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) working group for the preanalytical phase (WG-PA)". Clinical Chemistry and Laboratory Medicine (CCLM). 51 (8): 1585–1593. doi:10.1515/cclm-2013-0283. PMID23729577.
^Ernst, DJ (July 2008). "States fail to follow California's lead in certifying phlebotomists". Medical Laboratory Observer. 40 (7): 40, 42. PMID18717500. GaleA182040780.
^Kwan, H (October 2008). "Rooster guarding hen house?". Medical Laboratory Observer. 40 (10): 6, 8. PMID18990788.
^Harty-Golder, Barbara (January 2003). "When should a phlebotomist ask for help with a difficult draw?". MLO: Medical Laboratory Observer. 35 (1): 48. PMID12561745. GaleA96892952.
^Ernst, DJ (October 1997). "Is the phlebotomist obsolete?". MLO: Medical Laboratory Observer. 29 (10): 30–4. PMID10173584. GaleA20076530.
^"Should non-phlebotomists be allowed to draw blood?". Clinical Leadership & Management Review. 15 (6): 426–8. November 2001. PMID11822275.